[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635334":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":46,"locations":52,"responsibleParty":72,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"IL13Rα2 + EGFR\u002FEGFRvIII Dual-Target CAR-NK","EXPERIMENTAL","Participants whose tumors meet eligibility thresholds for IL13Rα2 and EGFR will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and EGFR\u002FEGFRvIII",[13,14,15,16],"Biological: Dual-target CAR-NK cells","Drug: Cyclophosphamide","Device: Intracranial catheter\u002Freservoir for locoregional delivery","Drug: Fludarabine",{"label":18,"type":10,"description":19,"interventionNames":20},"IL13Rα2 + B7-H3 (CD276) Dual-Target CAR-NK","Participants whose tumors meet eligibility thresholds for IL13Rα2 and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and B7-H3.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"EGFR\u002FEGFRvIII + B7-H3 (CD276) Dual-Target CAR-NK","Participants whose tumors meet eligibility thresholds for EGFR (and\u002For EGFRvIII) and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing EGFR\u002FEGFRvIII and B7-H3.",[13,14,15,16],[26,32,37,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Dual-target CAR-NK cells","Dual-target CAR-NK cells (IL13Rα2\u002FEGFR\u002FEGFRvIII construct):\n\nAllogeneic natural killer (NK) cells genetically engineered to express a chimeric antigen receptor (CAR) designed to recognize tumor-associated antigens including IL13Rα2, EGFR, and EGFRvIII. This multi-targeting strategy aims to enhance tumor recognition, reduce antigen escape, and improve cytotoxic activity against heterogeneous tumor cell populations. The engineered CAR-NK cells are administered via locoregional delivery (e.g., intracavitary or through an Ommaya reservoir) to achieve targeted anti-tumor effects while minimizing systemic toxicity.",[22,18,9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Cyclophosphamide","An alkylating chemotherapy agent used as part of lymphodepleting conditioning prior to CAR-NK cell infusion to enhance cell expansion, persistence, and anti-tumor activity.",[22,18,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"DEVICE","Intracranial catheter\u002Freservoir for locoregional delivery","A device (e.g., Ommaya reservoir) implanted in the brain to enable direct, repeated administration of CAR-NK cells or other therapies into the tumor site or cerebrospinal fluid, improving local drug delivery and reducing systemic exposure.",[22,18,9],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":31},"Fludarabine","A purine analog chemotherapy used in lymphodepletion prior to CAR-NK cell therapy to enhance the expansion, persistence, and anti-tumor activity of the infused cells.",[22,18,9],[47],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":62,"coordinates":63},"Point",[64,65],114.0683,22.54554,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":70,"phoneExt":31,"email":71},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100635334","phase-1-dual-targeting-car-nk-cells-for-recurrentprogressive-glioblastoma-and-high-grade-glioma-100635334",false,"NCT07551336","Dual-Targeting CAR-NK Cells for Recurrent\u002FProgressive Glioblastoma and High-Grade Glioma","A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR\u002FEGFRvIII, and\u002For B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.\n* Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.\n* Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rα2, EGFR (wild-type) and\u002For EGFRvIII, B7-H3 (CD276).\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.\n* Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).\n* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).\n* Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Requirement for high-dose systemic corticosteroids (e.g., \\>4 mg\u002Fday dexamethasone equivalent) within 7 days prior to lymphodepletion\u002Finfusion (physiologic replacement permitted).\n* Prior gene-modified cellular therapy (e.g., prior CAR-T\u002FCAR-NK) within 6 months, or prior therapy targeting IL13Rα2, EGFR\u002FEGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.\n* Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).\n* Uncontrolled seizures despite optimal medical therapy.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.","ALL","18 Years","75 Years",{"count":85,"type":86},36,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR\u002FEGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.",[92,93,94,95,96],"Malignant Glioma","High-Grade Gliomas","Glioblastoma","Recurrent High-Grade Gliomas","Recurrent Glioblastoma",[98,99,100,101,102,103,104,105,106,107],"CAR-NK","Dual targeting","Biomarker-guided","IL13Rα2","EGFR","EGFRvIII","B7-H3 (CD276)","Locoregional","Intracavitary","Ommaya reservoir","2026-04-18",{"date":110,"type":111},"2026-04-24","ACTUAL",{"date":113,"type":111},"2026-03-02",{"date":115,"type":86},"2028-04-17",{"name":5,"class":6},1]